Clinical Trial Leader (m/f)

 

Clinical Trial Leader (m/f) MorphoSys AG Planegg Leads Clinical Trial Team (CTT) in operationalizing protocol; creates trial level timelines and ensures all trial deliverables are met with high quality on time and within budget.

As One Of The Lead­ing Public Biotech Com­pa­nies In Eu­rope We Are Com­mitt­ed To De­vel­op­ing The Medicines Of The Fu­ture Build­ing On Our Port­fo­lio Of In­no­va­tive Anti­body Tech­nolo­gies We Are Ac­tive­ly Pur­su­ing New Ther­a­peu­tic Ap­proach­es In Close Col­lab­o­ra­tion With The World´s Fore­most Phar­ma­ceu­ti­cal Com­pa­nies And In­creas­ing­ly Un­der Our Own Ini­tia­tive Guid­ed By Mu­tu­al Re­spect And Trust Each Mem­ber Of The Team Is Giv­en The Op­por­tu­ni­ty To De­vel­op And Flour­ish Within This Exc­it­ing And In­spir­ing En­vi­ron­ment Join Us In Planegg Near Mu­nich We Would Like To Fill The Following Vacancy As Soon As Possible: Clinical Trial Leader (m/f) Referencenumber 169-2017 Your Responsibilities: Leads Clinical Trial Team (ctt) In Operationalizing Protocol Creates Trial Level Timelines And Ensures All Trial Deliverables Are Met With High Quality On Time And Within Budget Ensures All Trial Related Documents Including Operational Plans And Systems (e G Clinical Database Irt And Etc) Required For Ethics / Regulatory Submissions And Trial Initiation Are Developed By The Ctt And Vendors Within The Specified Timelines Manages Trial Allocation And Coordination / Management Of Activities Leading To Selection And Initiation Of Sites Ensures Trial-level And Site-level Readiness For First Site Initiation Plans Drives And Facilitates Investigator Meetings Or Equivalent Investigator Training With Ctt And Vendors Prepares Implements And Manages Vendors Including Their Sub-contractors And Ensures Oversight Of Trial Activities Outsourced To The Vendors In Collaboration With Ctt Manages And Coordinates Investigational Medicinal Products (imp) And Non-drug Supplies Across Regions And Countries And Ensures Final Drug Accountability Manages Overall Trial Conduct To Trial Close Out In Coordination With Ctt And Vendors   Collects Tracks And Communicates Trial Status For Enrollment Timelines Data Entry / Queries Trial Materials Provides Updates To Relevant Internal / External Boards  Manages Trial Budget Including Completion Of Grant Plan Specifications Obtains Relevant Internal Board Approvals Revises Budget When Applicable And Reconciles At Trial Close Out Collaborates With Clinical Program Leader To Define The Scope Of Responsibilities Of Operational And Medical / Clinical Data Review Within The Data Management Plan Or Equivalent To Ensure Ongoing Quality Data Review Provides Operational Support For Clinical Study Report (e G Appendices) Ensures Complete Close Out Of All Sites (vendor Materials Budget) Ensures Inspection / Audit Readiness Including Trial Master File Documentation Your Requirements: Ideally Min Five Years Operational Experience In Planning / Executing / Reporting Clinical Trials Thorough Knowledge Of Good Clinical Practice Regulatory Processes And Clinical Development Process Experience With Health Authority Inspections (fda And / Or Emea) Preferred Demonstrated Ability To Effectively Manage Trial Budget Strong Leadership And Project Management Skills Excellent In Negotiation And Conflict Resolution Ability To Influence Without Authority Ability To Lead A Global Cross-functional Team (including External Partner) In A Matrix Environment Strong Interpersonal Skills Ability To Work Under Pressure Resolve Issues Independently And Understand When To Escalate Fluent English (oral And Written)   Thank You For Your In­ter­est We Are Look­ing For­ward To Re­ceiv­ing Your Perti­nent Ap­pli­ca­tion Doc­u­ments For Your Ap­pli­ca­tion Please Use Ex­clu­sive­ly Our Ca­reer Por­tal Wwwcom/careers We Do Not On­ly Of­fer Ex­cel­lent Ca­reer Prospects But Sup­port You From The Very Start - Al­so Help­ing You Move Ag Semmelweisstraße 7 82152 Planegg Clinical Trial Manager Leader Management Klinisch Analytik Labor Studie Development Research Organisation Dokumentation Überwachung Betreuung Business Manage Entwicklung Forschung Pharma Bio Pharmatechnologie Biotechnologie Technologie Technologe Biotechnologe Pharmatechnologe Clinical Trial Manager Leader Management Klinisch Analytik Labor Studie Development Research Organisation Dokumentation Überwachung Betreuung Business Manage Entwicklung Forschung Pharma Clinical Trial Leader (m/f) Leads Clinical Trial Team (CTT) In Operationalizing Protocol Creates Trial Level Timelines And Ensures All Trial Deliverables Are Met With High Quality On Time And Within Budget Planegg Clinical Trial Manager Leader Management Klinisch Analytik Labor Studie Development Research Organisation Dokumentation Überwachung Betreuung Business Manage Entwicklung Forschung Pharma

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